Note: Members must meet the clinical indications as well as the general individual selection criteria for the transplantation to be considered medically necessary.

Medically Necessary:

Kidney transplantation from a deceased or a living donor is considered medically necessary for selected individuals with end stage renal disease. The clinical indications leading to end stage renal disease include, but are not limited to, one of the conditions listed below.

RetransplantationRepeat transplant due to acute or chronic graft failure is considered medically necessary.

Simultaneous Liver Kidney TransplantationKidney transplant as part of a simultaneous liver kidney (SLK) transplantation is considered medically necessary when criteria for liver transplantation are met and when one of the following are met:

The individual has acute renal failure secondary to either hepatorenal syndrome or acute kidney injury; either of which have required at least six weeks of dialysis therapy; OR

The individual has chronic kidney disease with a measured creatinine clearance of less than or equal to 30cc/min; OR

Kidney transplantation for conditions other than end stage renal disease is considered not medically necessary.

Kidney transplantation as part of a simultaneous liver kidney (SLK) transplant is considered not medically necessary, if one of the above SLK criteria is not met.

Note: For multi-organ transplant requests, criteria must be met for each organ requested. In those situations, an individual may present with a concurrent medical condition which may be considered an exclusion or a comorbidity that would preclude a successful outcome, but would be treated with the additional organ transplant. Such cases will be reviewed on an individual basis for coverage determination to assess the member's candidacy for transplantation.

General Individual Selection Criteria

In addition to having one of the clinical indications above, the member must not have a contraindication as defined by the American Society of Transplantation in Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation (2001) listed below.*

Absolute Contraindications- for Transplant Recipients include, but are not limited to, the following:

Metastatic cancer

Ongoing or recurring infections that are not effectively treated

Serious cardiac or other ongoing insufficiencies that create an inability to tolerate transplant surgery

Serious conditions that are unlikely to be improved by transplantation as life expectancy can be finitely measured

Demonstrated patient noncompliance, which places the organ at risk by not adhering to medical recommendations

Potential complications from immunosuppressive medications are unacceptable to the patient

Acquired immune deficiency syndrome (AIDS) (diagnosis based on Centers for Disease Control and Prevention [CDC] definition of CD4 count, 200cells/mm3) unless the following are noted:

CD4 count greater than 200cells/mm3 for greater than 6 months

HIV-1 RNA undetectable

On stable anti-retroviral therapy greater than 3 months

No other complications from AIDS (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidioidmycosis, resistant fungal infections, Kaposi's sarcoma or other neoplasm)

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Backbench standard preparation of living donor renal allograft (open or laparoscopic) prior to transplantation, including dissection and removal of perinephric fat and preparation of ureter(s), renal vein(s), and renal artery(s), ligating branches, as necessary

50327

Backbench reconstruction of cadaver or living donor renal allograft prior to transplantation; venous anastomosis, each

50328

Backbench reconstruction of cadaver or living donor renal allograft prior to transplantation; arterial anastomosis, each

50329

Backbench reconstruction of cadaver or living donor renal allograft prior to transplantation; ureteral anastomosis, each

In 2011, nearly 20 million Americans were reported to have chronic kidney disease (CKD), with nearly 113,000 requiring initiation of treatment for kidney failure known as end stage renal disease (ESRD) each year (CDC, 2014). There was a steady rise in the rate of ESRD from 1980 to 2011; the incident rate of ESRD has started to decline. In September of 2014, the Organ Procurement and Transplantation Network reported nearly 79,000 Americans on the United States wait list for kidney transplantation with approximately 17,000 kidney transplants performed annually (OPTN, 2014).

A kidney transplant involves the surgical removal of a kidney from a deceased or living donor and implanted into a recipient. A donor left kidney is usually transplanted to the right iliac fossa with the renal artery anastomosed end-to-end to the hypogastric artery and the renal vein end-to-side to the common iliac vein. The ureter is implanted into the bladder and (under special conditions) a uretero-ureteral anastomosis or ureteropyelostomy may be performed.

Hepatorenal syndrome is a severe complication of liver cirrhosis or other severe liver disease. Features of hepatorenal syndrome are renal dysfunction caused by abnormalities in the arterial circulation and the vasoactive systems, resulting in renal vasoconstriction and renal insufficiency. There are two types of hepatorenal syndrome. Type I hepatorenal syndrome occurs when renal function is rapidly reduced and has an ominous prognosis which is usually reversed by liver transplantation. Type II hepatorenal syndrome occurs when renal failure does not progress rapidly. It can be quite difficult to distinguish these two conditions in individuals with severe liver disease. Liver transplantation is the recognized treatment for hepatorenal syndrome (Davis, 2005; Marik, 2006).

Concern has been raised since the introduction of the MELD (model for end-stage liver disease) prioritization for liver transplant that some recipients that undergo combined liver and kidney transplantation may have reversible renal failure. To address this issue, the American Society of Transplantation and American Society of Transplant Surgeons met in March 2006 to review post-MELD data on the impact of renal function on liver waitlist and transplant outcomes and the result of simultaneous liver kidney transplantation. This committee issued a consensus statement with regard to simultaneous liver-kidney (SLK) transplantation summarized below (Davis, 2007):

In the setting of chronic kidney disease, a measured creatinine clearance of less than or equal to 30cc/min was considered the appropriate threshold for SLK transplantation.

In the setting of acute renal failure secondary to hepatorenal syndrome or acute kidney injury, renal dysfunction requiring dialysis reflects a decreased capacity for renal recovery and SLK transplantation is considered appropriate. The committee through consensus established a six (6) weeks dialysis duration threshold prior to SLK transplantation.

In the setting of acute renal failure including hepatorenal syndrome not requiring dialysis, SLK transplantation was not felt to be medically necessary or appropriate. In reaching this consensus, the committee determined that liver transplant recipients with a GFR of less than 30cc/min had a 1-year post-transplant survival of 81.5% and only 25/1648 (1.5%) of these recipients were listed for kidney transplant within a year of liver transplantation.

There is a paucity of large prospective randomized controlled trials in the peer-reviewed literature to support the use of combined kidney liver transplantation when the duration of renal failure and dialysis is less than 6 weeks.

Definitions

Allotransplantation: The transfer of cells, tissues, or whole organs from one individual to another within the same species.

Chronic renal disease: The permanent loss of kidney function.

End stage renal disease: Persistent decline in renal function as documented by falling creatinine clearance in an individual diagnosed with a renal disease whose natural history is progression to renal impairment requiring renal replacement (dialysis or transplant).